Quality Assurance Manager Poland & Baltics / Responsible Person at Pharmaceutical Warehouse

Description Overview

Scope of the Role

As Responsible Person in Pharmaceutical Wholesaler:

• Ensuring effective implementation, maintenance, and continuous improvement of the Quality Management System (QMS).
• Overseeing all activities performed under the wholesale distribution authorization and ensuring complete, accurate documentation.
• Managing quality-related training and supporting continuous competence development across the organization.
• Leading recall and quarantine actions and coordinating annual mock recall exercises.
• Handling and resolving quality complaints in a timely and efficient manner.
• Ensuring proper qualification and approval of suppliers, customers, and subcontractors.
• Reviewing and approving subcontracted activities that may affect GDP compliance.
• Leading internal audit activities and driving timely implementation of CAPA actions.
• Deciding on the disposal of non-compliant, returned, or recalled medicinal products.
• Approving products for return to saleable stock when justified.
• Ensuring full compliance with Polish Pharmaceutical Law, GDP requirements, and internal quality standards.

As Quality Assurance Manager:

• Managing, maintaining, and continuously improving the Quality Management System (QMS) in line with corporate standards and local requirements.
• Developing, reviewing, and updating local procedures and controlled documents.
• Representing the company in global and local quality teams.
• Providing quality governance and communicating key quality updates to senior management.
• Leading deviation and CAPA processes, including assessment, decision-making, and closure of corrective actions.
• Supporting global Quality teams in complaint investigations and management of non-conforming materials.
• Managing communication with authorities and customers regarding quality issues, complaints, and recalls.
• Preparing, reviewing, and maintaining Quality Assurance Agreements.
• Planning and supporting internal, external, and corporate audits and inspections (Quality & GDP).
• Managing internal quality trainings for the local Business Unit and supporting Supply Operations in distribution-related quality topics.
• Completing ZSMOPL reporting and ensuring data accuracy.

Experience Required

• Master of Pharmacy with a valid License.
• Previous experience as Responsible Person or Deputy Responsible Person in a Pharmaceutical Wholesaler.
• Professional experience in Quality Assurance within the pharmaceutical industry.
• Solid understanding of Pharmaceutical Law, QMS, and GDP requirements.
• Active driver’s license.
• Very good command of English (written and spoken).
• Working knowledge of GMP (nice to have).
• Experience in team leadership or people management (nice to have).
• Experience with SAP, Reflex, TrackWise or similar systems (nice to have).
• Strong analytical skills, attention to detail, and the ability to work effectively in a compliance‑driven environment.
• Excellent communication skills and the ability to collaborate with cross‑functional and international teams.
• Proactive mindset, strong sense of responsibility, and readiness to support quality-related decision-making.